GMP Cytokines Brochure

PeproGMP® Cytokines:

Helping Unlock the Promise of Cellular Therapies and Regenerative Medicines



In response to our clients’ needs, and the requirements of the cell and gene therapy markets, we are pleased to introduce our new state-of-the-art manufacturing facility in Cranbury, NJ.

The rapidly evolving field of regenerative medicine offers exciting opportunities to develop new solutions for an array of diseases, injuries, and genetic disorders. With the recent expansion of our new facility, PeproTech is able to meet the demand of the advancing markets in cell, gene, and tissue therapies. Our 65,000 square foot facility has significantly more square footage for GMP cleanrooms and supports the manufacturing of our bacterial expressed GMP products and expansion into cell culture derived GMP products.

    

Consistent with U.S. federal requirements and best practices for cell therapy, gene  therapy, and tissue-engineered products for clinical applications, PeproGMP® Cytokines are  manufactured and tested in compliance with relevant US FDA GMP (Good Manufacturing Practices) regulations and the ISO 9001 quality management systems standard, without the use of animal-derived materials.

PeproTech's GMP Products

Product Description

Catalog Number

Size

PeproGMP® Human Activin A GMP120-14E-50UG 50µg
PeproGMP® Human Activin A GMP120-14E-100UG 100µg
PeproGMP® Human IL-2 GMP200-02-50UG 50µg
PeproGMP® Human IL-2 GMP200-02-100UG 100µg
PeproGMP® Human IL-2 GMP200-02-1MG 1mg
PeproGMP® Human IL-3 GMP200-03-50UG 50µg
PeproGMP® Human IL-3 GMP200-03-100UG 100µg
PeproGMP® Human IL-3 GMP200-03-1MG 1mg
PeproGMP® Human IL-6 GMP200-06-10UG 10µg
PeproGMP® Human IL-6 GMP200-06-100UG 100µg
PeproGMP® Human IL-7 GMP200-07-50UG 50µg
PeproGMP® Human IL-7 GMP200-07-100UG 100µg
PeproGMP® Human IL-15 GMP200-15-50UG 50µg
PeproGMP® Human IL-15 GMP200-15-100UG 100µg
PeproGMP® Human IL-21 GMP200-21-50UG 50µg
PeproGMP® Human IL-21 GMP200-21-100UG 100µg
PeproGMP® Human IL-21 GMP200-21-1MG 1mg
PeproGMP® Human EGF GMP100-15-100UG 100µg
PeproGMP® Human EGF GMP100-15-500UG 500µg
PeproGMP® Human EGF GMP100-15-1MG 1mg
PeproGMP® Human FGF-basic GMP100-18B-25UG 25µg
PeproGMP® Human FGF-basic GMP100-18B-100UG 100µg
PeproGMP® Human FGF-basic GMP100-18B-1MG 1mg
PeproGMP® Human Flt3-Ligand GMP300-19-50UG 50µg
PeproGMP® Human Flt3-Ligand GMP300-19-100UG 100µg
PeproGMP® Human Flt3-Ligand GMP300-19-1MG 1mg
PeproGMP® Human Heregulinβ-1 GMP100-03-50UG 50µg
PeproGMP® Human Heregulinβ-1 GMP100-03-100UG 100µg
PeproGMP® Human Heregulinβ-1 GMP100-03-1MG 1mg
PeproGMP® Human KGF GMP100-19-50UG 50µg
PeproGMP® Human KGF GMP100-19-100UG 100µg
PeproGMP® Human KGF GMP100-19-1MG 1mg
PeproGMP® Human LIF GMP300-05-50UG 50µg
PeproGMP® Human LIF GMP300-05-100UG 100µg
PeproGMP® Human PDGF-AA GMP100-13A-50UG 50µg
PeproGMP® Human PDGF-AA GMP100-13A-100UG 100µg
PeproGMP® Human SCF GMP300-07-50UG 50µg
PeproGMP® Human SCF GMP300-07-100UG 100µg
PeproGMP® Human SCF GMP300-07-1MG 1mg
PeproGMP® Human TPO GMP300-18-50UG 50µg
PeproGMP® Human TPO GMP300-18-100UG 100µg
PeproGMP® Human VEGF165 GMP100-20-50UG 50µg
PeproGMP® Human VEGF165 GMP100-20-100UG 100µg
PeproGMP® Human VEGF165 GMP100-20-1MG 1mg

We are continually adding new GMP products. Please contact [email protected] for our most up-to-date product list.


Quality Management

PeproTech ensures that all aspects of our quality management system—from management of raw materials and equipment to facilities maintenance (environmental monitoring), manufacturing processes, audits, and inspection processes—are in compliance with relevant US FDA GMPs and all applicable regulatory and standards requirements.

The benefits of our rigorous process are clear: PeproGMP® Cytokines offer safety, purity, and simplified use in ex vivo manufacturing processes, as described in USP (United States Pharmacopeia) Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products. 

All PeproGMP® Products are manufactured using animal-derived component-free materials

  • Controlled-certified ISO7 and ISO8 Cleanrooms

  • Qualification & Validation Program

  • Materials Management (Including supplier qualification, controlled & qualified raw materials)

  • 100% Traceability

  • Personnel Training Program

  • Environmental Monitoring

  • Equipment Calibration & Maintenance

  • Rigorous Quality Control Program

  • Documentation Control & Records

  • Stability Program

  • Controlled Processes

  • QA Review & Support

  • Master Quality & Supply Agreement

  • Aseptic Techniques & Sterile Filtration

  • Management Review

  • Compliant and Recall Procedures

Quality Control

We perform extensive quality control testing to verify that PeproGMP® Cytokines meet rigorous standards for purity, identity, safety, activity, and lot-to-lot consistency.

Identity and Purity

  • N-terminal amino acid sequence analysis
  • Molecular weight determination by mass spectrometry
  • Reversed-phase HPLC analysis
  • SDS-PAGE
  • Western blotting

Protein Content

  • UV spectroscopy
  • SDS-PAGE

Safety Testing

  • Residual E. coli DNA testing
  • Sterility Testing (USP Standards): beginning, middle and end processes
  • Low Endotoxin
  • Mycoplasma

Biological Activity

  • Specific activity determined by product-specific in vitro bioassay, against reference standard and (when applicable) against WHO standards

Documentation

  • Certificate of Analysis (COA)
  • Certificate of Origin (COO)
  • Safety Data Sheet (SDS)

 

Q&A

1. Can I use PeproGMP® Cytokines for GMP manufacturing of investigational products, and for manufacturing commercial therapeutic products?

Yes, PeproGMP® Cytokines are intended for use in GMP manufacturing of investigational or marketed clinical products, such as cell therapy, gene therapy, tissue-engineered products, combination products, or other Advanced Therapy Medicinal Products.

PeproGMP® Cytokines are not, however, therapeutic products or excipients, and hence are not suitable for direct administration to humans. See USP Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products for more information, or contact PeproTech Technical Support.  
 
2. What is the risk classification for PeproGMP® Cytokines?

PeproGMP® Cytokines are classified as Tier 2 under USP Chapter <1043>:

Tier 1: Low-risk, highly qualified materials (therapeutic drug or biologic, medical device)
Tier 2: Low-risk, well-characterized materials, produced in compliance with GMPs, and intended to be used as ancillary materials
Tier 3: Moderate risk, not for use as ancillary materials
Tier 4: High-risk materials  

3. Is the facility where PeproGMP® Cytokines are manufactured GMP-certified by FDA? Has FDA inspected PeproTech? How would my QA department qualify PeproTech and PeproGMP® Cytokines?

The US FDA does not perform inspections or GMP certification of manufacturing facilities for ancillary reagents. In some countries, the national regulatory authority does inspect and certify GMP manufacturing facilities for all types of products, but FDA GMP inspections are limited to manufacturing facilities for therapeutic products and medical devices.

PeproTech's GMP Cytokines are manufactured in accordance with GMPs, under a rigorous ISO 9001-compliant quality system. All aspects of manufacturing, testing, labeling, and packaging are stringently controlled, validated, and monitored by PeproTech QA. PeproTech provides detailed Certificates of Analysis and Certificates of Origin for all PeproGMP® product lines. SDS documents are also available.  
 
4. Are PeproGMP® Cytokines animal-origin free and human-origin free?

Yes. Cytokines in the PeproGMP® line are manufactured using defined media, enzymes, and chemicals, none of which are derived from animal or human origin.  
 
5. Do PeproGMP® Cytokines have the same biological properties as the PeproTech research-grade/ animal-free-grade cytokines I have been using for R&D studies?

Yes. PeproGMP® Cytokines are functionally equivalent to their research-grade counterparts.  
 
6. How are PeproGMP® Cytokines shipped?

The products are lyophilized, making them stable at a wide range of temperatures. Shipping is at ambient temperature. Upon request and at an additional cost, these products can be shipped on ice packs or dry ice.  
 

References

  • USP Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
  • FDA Guidance: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
  • FDA Guidance: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
  • EC Regulation 1394/2007 on Advanced Therapy Medicinal Products
  • EC Directive 2009/120/EC - Medicinal Products for Human Use as Regards Advanced Therapy Medicinal Products
  • www.iso.org/iso/home/standards/management-standards/iso_9000.htm